4801 Aplicare Povidone-iodine

SPL v8

SPL

SPL Set ID 91aef86d-ce8b-45be-bce9-74450292e0cd

Route

TOPICAL

Published

Effective Date 2015-04-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (10 mg)

Inactive Ingredients

Citric Acid Monohydrate Sodium Phosphate, Dibasic Sodium Hydroxide Nonoxynol-9 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 1998-01-01

Description

Povidone-iodine 10% (equivalent to 1% available iodine)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine 10% (equivalent to 1% available iodine)

Use

• antiseptic skin preparation
• single use when used for patient preoperative skin preparation

Warnings

For external use only
Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Directions

apply topically as needed

Do Not Use

• in the eyes
• on individuals allergic or sensitive to iodine

Package Label

Active Ingredient

Povidone-iodine 10%

(equivalent to 1% available iodine)

Other Information

• not made with natural rubber latex
• for hospital or professional use only

Inactive Ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Questions Or Comments?

www.medline.com 1 800-Medline

Manufacturing Information

Manufactured in USA by Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA.

www.medline.com 1-800-Medline

REF: APL82344K

V1 RG24HND

Stop Use and Ask A Doctor If

• infection occurs
• redness, irritation, swelling or pain persists or increases

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Ask A Doctor Before Use If Injuries Are

• deep puncture wounds
• serious burns

Structured Label Content

Use

• antiseptic skin preparation
• single use when used for patient preoperative skin preparation

Purpose

Antiseptic

Warnings

For external use only
Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Directions

apply topically as needed

Do Not Use (Do not use)

• in the eyes
• on individuals allergic or sensitive to iodine

Package Label

Active Ingredient (Active ingredient)

Povidone-iodine 10%

(equivalent to 1% available iodine)

Other Information (Other information)

• not made with natural rubber latex
• for hospital or professional use only

Inactive Ingredients (Inactive ingredients)

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Questions Or Comments? (Questions or comments?)

www.medline.com 1 800-Medline

Manufacturing Information

Manufactured in USA by Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA.

www.medline.com 1-800-Medline

REF: APL82344K

V1 RG24HND

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• infection occurs
• redness, irritation, swelling or pain persists or increases

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Ask A Doctor Before Use If Injuries Are (Ask a doctor before use if injuries are)

• deep puncture wounds
• serious burns

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "• antiseptic skin preparation • single use when used for patient preoperative skin preparation", "Purpose": "Antiseptic", "Warnings": "For external use only Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.", "Directions": "apply topically as needed", "Do not use": "• in the eyes • on individuals allergic or sensitive to iodine", "Active ingredient": "Povidone-iodine 10% (equivalent to 1% available iodine)", "Other information": "• not made with natural rubber latex • for hospital or professional use only", "Inactive ingredients": "citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water", "Questions or comments?": "www.medline.com 1 800-Medline", "Manufacturing Information": "Manufactured in USA by Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA. www.medline.com 1-800-Medline REF: APL82344K V1 RG24HND", "Stop use and ask a doctor if": "• infection occurs • redness, irritation, swelling or pain persists or increases", "Keep out of reach of children.": "In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.", "Ask a doctor before use if injuries are": "• deep puncture wounds • serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:55.314883 · Updated: 2026-03-14T23:09:59.416921